Approved Gene Testing (M00041, V14)

After a review of the current available literature, the MolDX Program has determined that testing for the following genes/gene components meets the Medicare criteria for a covered service. This listing has been updated with 2016 CPT codes.

#

CPT Code

Description

1.

81170

ABL1, ga

2.

81206

BCR_ABL1, majbp qual quant (p210)

3.

81207

BCR_ABL1, minbp qual quant (p190)

4.

81208

BCR_ABL1, other bp qual quant

5.

81210

BRAF, V600E

6.

81211

BRCA1, BRCA2, fgs cdup_del

7.

81217

BRCA2, kfv

8.

81218

CEBPA, fgs

9.

81225

CYP2C19, cv

10.

81226

CYP2D6, cv

11.

81235

EGFR, cv

12.

81245

FLT3, ITD

13.

81246

FLT3, TKD

14.

81256

HFE, cv

15.

81261

IGH, amp

16.

81262

IGH, dp

17.

81263

IGH, var reg

18.

81264

IGK, gr

19.

81265

STR

20.

81266

STR add (for transplants)

21.

81267

Chimerism, no cell

22.

81268

Chimerism, with cell

23.

81270

JAK2, V617F

24.

81272

KIT, tsa

25.

81273

KIT, D816

26.

81275

KRAS, codons 12 and 13

27.

81275

KRAS, exon 1

28.

81276

KRAS, addvar

29.

81287

MGMT, ma

30.

81288

MLH1, ma

31.

81292

MLH1, fgs

32.

81293

MLH1, kfv

33.

81294

MLH1, dup_del

34.

81295

MSH2, fgs

35.

81296

MSH2, kfv

36.

81297

MSH2, dup_del

37.

81298

MSH6, fgs

38.

81299

MSH6, kfv

39.

81300

MSH6, dup_del

40.

81301

MSI

41.

81310

NPM1, exon 12

42.

81311

NRAS, ex 2-3

43.

81313

PCA3

44.

81314

PDGFRA, tsa

45.

81315

PML_RAR, cbp

46.

81316

PML_RAR, sbp

47.

81317

PMS2, fgs

48.

81318

PMS2, kfv

49.

81319

PMS2, dup_del

50.

81321

PTEN, fgs

51.

81322

PTEN, kfv

52.

81323

PTEN, dup_del

53.

81332

SERPINA, cv

54.

81340

TRB, beta

55.

81341

TRB, dp

56.

81342

TRG, gamma

57.

81370

HLA I-II, lr ant

58.

81371

HLA I-II, lr verification

59.

81372

HLA I, lr complete

60.

81373

HLA I, lr locus ea

61.

81374

HLA I, lr 1 ant.

62.

81375

HLA II, lr DRB1/3/4/5, DQB1

63.

81376

HLA II, lr locus ea

64.

81377

HLA II, lr antigen ea

65.

81378

HLA I-II, hr A, B, C, DRB1

66.

81379

HLA I, hr complete

67.

81380

HLA I, hr locus ea

68.

81381

HLA I, hr allele ea

69.

81382

HLA II, hr locus ea

70.

81383

HLA II, hr allele ea

71.

81400

ACE, idv

72.

81400

F13B, V34L

73.

81400

F2, 1199G>A

74.

81400

F5, HR2

75.

81400

F7, R353Q

76.

81400

FGB, -455G>A

77.

81400

HPA, panel

78.

81400

HPA-1

79.

81400

HPA-2

80.

81400

HPA-3

81.

81400

HPA-4

82.

81400

HPA-5

83.

81400

HPA-15

84.

81400

IL28B, rs12979860

85.

81400

SERPINE1, 4G

86.

81401

ABL1, T315I

87.

81401

CBFB_MYH11, cv

88.

81401

CCND1_IGH, ta majbp qual qual

89.

81401

E2A_PBX1, ta qual quan,

90.

81401

EML4_ALK, ta

91.

81401

ETV6_RUNX1, ta qual quan

92.

81401

EWSR1_ERG, ta qual quan

93.

81401

EWSR1_FLI1, ta qual quan

94.

81401

EWSR1_WT1, ta qual quan

95.

81401

F11, cv

96.

81401

FIP1L1_PDGFR, qual quan

97.

81401

FOXO1_PAX3, ta, qual quan

98.

81401

FOXO1_PAX7, ta, qual quan

99.

81401

IGH/BCL2, sbp

100.

81401

MUTYH, cv

101.

81401

PAX8_PPARG, ta

102.

81401

RUNX1_RUNX1T1, ta qual quan

103.

81401

TPMT, cv

104.

81401

TYMS

105.

81401

VWF, cv

106.

81402

IGH_BCL2, majbpr_mcrbp qul_qun

107.

81402

KIT, cv

108.

81403

EPCAM, kfv

109.

81403

F8, intron 1 and 22a

110.

81403

HEA, gs

111.

81403

IDH1, exon 4

112.

81403

IDH1_ IDH2, exon 4 panel

113.

81403

IDH2, exon 4

114.

81403

JAK2, exon 12 and 13

115.

81403

MUTYH, kfv

116.

81403

117.

81403

RET, kfv

118.

81403

VHL, dup_del

119.

81403

VWF, tsa 2A, 2B, 2M

120.

81404

CDKN2A, fgs

121.

81404

NRAS, exon 1, 2

122.

81404

PRSS1, fgs

123.

81404

RET, cv

124.

81404

VHL, fgs

125.

81405

MEN1, fgs

126.

81405

RET, tsa

127.

81405

VWF, tsa 2N

128.

81406

RET, fgs

129.

81445

Tsa panel, solid organ neoplasm, 5-50 genes

130.

81450

Tsa panel, hematolymphoid neoplasm, 5-50 genes

131.

81455

Tsa panel, solid organ or hematolymphoid neoplasm, 51 or >

132.

81479

ALK

133.

81479

BCR_ABL1, 210 + 190

134.

81479

BCR_ABL1, 210 + 190 +other

135.

CALR_MPL

136.

81479

CYP2D6, CYP2C19

137.

81479

ERBB2

138.

81479

ERCC1

139.

81479

FLT3, ITD + TKD

140.

81479

HER2

141.

81479

IGH, IGK

142.

81479

MYD88, L265P

143.

81479

NRAS, 2,3,4

144.

81479

RET/PTC

145.

81479

ROS1

146.

81479

TRB/TRG

The following tests have completed the MolDX Technical Assessment Process and limited coverage has been established. Please review the companion policy and/or article for test specific information.

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Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.